ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW
FDA device recall Z-1489-2014 · posted 2014-04-23 · Terminated
Recall details
- Recalling firm
- Ev3, Inc.
- Reason for recall
- Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling.
- Action taken
- Consignees were sent a Covidien "Urgent Product Recall" letter dated April 09, 2014. The letter described the problem and the product involved in the recall. The letter described the required actions which included to immediately quarantine and discontinue use of the affected devices and to return affected product. Requested consignees to complete the Verification Form and return it to their Covidien Sales Representative. For questions they can contact Covidien Customer Service at 1-800-716-6000.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- DQY
- Quantity affected
- 39 units (31 OUS, 8 US)
- Distribution
- Worldwide Distribution-USA including the states of WV, TX, OK, IN, NY, TX, and NC, and the countries of AUSTRALIA, ISRAEL, TURKEY, UNITED KINGDOM, ITALY, FRANCE, and CHINA.
- Date initiated
- 2014-04-09
- Date posted
- 2014-04-23
- Date terminated
- 2014-10-06
- Location
- Plymouth, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVERCROSS 0.035 OTW PTA DILATION CATHETER (K103322) | Ev3, Inc. | 2010-12-06 |
| EVERCROSS .035 OTW PTA DILATATION CATHETER (K082579) | Ev3, Inc. | 2008-11-20 |